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Completed

NCT Number: NCT05151770

Type 1 Diabetic Post Prandial Glycemia Evaluation Using an Algorithm

The aim of this study is to demonstrate the efficacy of an algorithm to anticipate the post prandial glycemic profile in type I diabetic patient.

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Key information

Conditions

Type I Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

APHM, Marseille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 1 diabetes
  • ≥ 18 years old
  • Hb1Ac<12%

Exclusion criteria

  • Patient without continuous glucose monitoring system
  • Disease other than diabetes (bulimia, anorexia…)
  • Dialysis patient
  • Known history of drug or alcohol abuse
  • Patient under judicial protection
  • Person deprived of liberty
  • Pregnant, parturient or breastfeeding woman
  • Patient in psychiatric care
  • Patient admitted to a health or social institution for purposes other than research
  • Any reasons that might interfere with the evaluation of the study objectives

Treatment and study plan

Measure of glycemia levels and comparison to algorithm predictions

Other

The study aims to evaluate the efficacy of a new algorithm in predicting the evolution of glycemia levels after a full meal. Glycemia levels measured during and after a full meal will be compared to the values predicted by the algorithm. Composition of the meals will also be collected.

Primary outcomes

  1. Algorithm efficacy

    Time frame: 15 days

    The Algorithm efficacy in predicting the risk or absence of risk of hyperglycemia two hours after taking a full meal is evaluated by comparing glycemic values calculated by the algorithm and those obtained using continuous glucose monitoring system measurements.

Secondary outcomes

  1. Algorithm efficacy (lower margin of error)

    Time frame: 15 days

    The Algorithm efficacy in predicting the risk or absence of risk of hyperglycemia two hours after taking a full meal is evaluated by comparing glycemic values calculated by the algorithm and those obtained using continuous glucose monitoring system measurements (the accepted margin of error is reduced by 25 to 50% when compared with primary outcome).

  2. Algorithm efficacy versus meal composition

    Time frame: 15 days

    Meals will be analyzed within different groups according to their respective nutritional index. For each group, algorithm prediction reliability will be determined.

  3. Influence of the age of the patients on algorithm results

    Time frame: 15 days

    The Algorithm efficacy will be analyzed according to the age of patients

  4. Influence of the BMI on algorithms results

    Time frame: 15 days

    Weight and height of patients will be combined to report BMI in kg/m2. Algorithm efficacy will be analyzed according to the BMI of patients

  5. Influence of the insulin administration on algorithm results

    Time frame: 15 days

    Data obtained from patients using insulin pumps will be compared to data obtained from patients using multiple daily insulin injections.

Sponsors and collaborators

Lead sponsor

M-DT1

Industry

Collaborators

  • Assistance Publique Hopitaux De Marseille
  • Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Registry information

Acronym: EGHYA

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 9, 2021
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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